FDA · official record K220392Substantially Equivalent

PAPAYA 3D & PAPAYA 3D Plus

Name: PAPAYA 3D & PAPAYA 3D Plus — FDA K220392
Creator: Genoray Co., Ltd.
Keywords: PAPAYA 3D & PAPAYA 3D Plus, PAPAYA 3D & PAPAYA 3D Plus, K220392, OAS, FDA

United StatesOASGenoray Co., Ltd.

Verified

Official record identity

FDA application number: K220392
Decision date: May 19, 2022
Published decision: Substantially Equivalent

Classification

Product code: OAS

Published parties

Applicant: Genoray Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2022-02-11
Review panel: Radiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 892.1750

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.